KardiaMobile 6L

Transmitters And Receivers, Electrocardiograph, Telephone

AliveCor, Inc.

The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile 6l.

Pre-market Notification Details

Device IDK220350
510k NumberK220350
Device Name:KardiaMobile 6L
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant AliveCor, Inc. 189 N. Bernardo Ave. Suite 100 Mountain View,  CA  94043
ContactSusan Noriega
CorrespondentPrabhu Raghavan
MDQR, LLC. 189 N. Bernardo Ave. Suite 100 Mountain View,  CA  94043
Product CodeDXH  
Subsequent Product CodeDPS
Subsequent Product CodeQDA
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-07
Decision Date2022-05-25

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